Study Design

A 28-week, prospective, single-site, open-label trial of 15 patients to assess the efficacy and safety of Acthar as adjunctive therapy in patients with moderately to severely active PsA who had not responded adequately to treatment1

Primary outcome measure in this study was ACR20 at Week 121

Secondary outcome measures included ACR20 at Week 24 and the following assessments at Weeks 12 and 241:

ACR50 and ACR70

Clinical Disease Activity Index (CDAI)

Psoriasis Area and Severity Index (PASI)*†

Physician global assessment

Patient global assessment

Tender/swollen joint count

Visual analogue scale (VAS) for measurement of pain by patients

Erythrocyte sedimentation rate (ESR)

C-reactive protein (CRP)

*The Psoriasis Area and Severity Index (PASI) is a combination of assessment measures in psoriatic patients. PASI assesses the severity of disease into a single score accounting for lesions and the area affected. The score ranges from 0 (no disease) to 72 (maximal disease).2

†Includes the PASI50 and PASI75 to determine if patients achieve 50% and 75% improvements respectively.1,3

Patient overview1

All patients had to meet ACR criteria for PsA and have moderately to severely active disease‡ that required either an increase in steroid dose or an add-on steroid despite standard-of-care therapy.§

Patients who were receiving NSAIDs must have been on stable doses for ≥4 weeks prior to initiation of Acthar, and those receiving any DMARDs or biologic agents had to have been treated for ≥8 weeks.

All noted brand names are registered trademarks of their respective owners.

‡Patients were diagnosed with PsA according to the Classification of Psoriatic Arthritis (CASPAR) study group criteria ≥6 months prior to screening, had ≥6 tender and ≥6 swollen joint counts, and had ≥30 minutes of morning joint stiffness.1

§Doses of oral corticosteroids must have been stable for ≥2 weeks prior to initiation of Acthar and not exceeded the equivalent of 10 mg of prednisone per day.1

Treatment overview1

Acthar was administered to patients from Week 0 through Week 24 via a single dose of 80 units/mL delivered subcutaneously twice weekly||

Patients received injections at the clinic at Week 0, Week 12, and Week 24. All other injections were self-administered

#Patient 12 did not complete treatment through Week 24 for an unknown reason.

Study limitations1

Results are based on a single-site trial of 15 patients and may not be fully representative of outcomes in the overall patient population. All patients were on other therapies. The clinical outcomes may not be solely attributable to Acthar. Acthar has not been formally studied in combination with other commonly used therapies for PsA.

Safety findings1

8 of the 15 patients completed treatment through Week 12.

Of the 7 patients who withdrew prior to Week 12, 3 experienced potential treatment-related adverse events: 2 had psoriasis that worsened and 1 had depression

The remaining 4 patients withdrew for other reasons unrelated to adverse events: 1 was lost to follow-up, 1 missed 2 weeks of dosing and was then lost to follow-up, 1 withdrew due to travel commitments, and 1 was noncompliant due to work schedule

There were no other potentially treatment-related adverse events identified during this study. In addition, there were no changes in blood pressure, body temperature, or blood glucose levels observed among any of the participating patients

7 of the 8 remaining patients completed treatment through Week 24.

1 patient did not complete the treatment for an unknown reason

Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.4

*Refractory PsA was defined as failure to achieve disease remission with previous treatment.

†The RAPID3 score is the sum of 3 patient self-reported scores on the Multidimensional Health Assessment Questionnaire (MDHAQ). Pain, physical function, and patient global assessment are rated by the patient on a 0-10 visual analogue scale (VAS).6 The score does not include physician assessment of tender or swollen joint count, peripheral joint symptoms, skin symptoms, dactylitis, enthesitis, nail symptoms, or spine symptoms typically associated with PsA.5,7 The final score is calculated by the treating healthcare professional and recorded on a 0-30 scale: 1-3=near remission; 4-6=low severity; 7-12=moderate severity; and 13-30=high severity.6,8

Treatment overview5

Acthar was initiated to help manage active disease or as a bridge therapy to manage symptoms during transition to new treatment

Study limitations5

Results are based on a retrospective case series of 9 patients and may not be fully representative of outcomes in the overall patient population. Some patients were on other therapies. The clinical outcomes may not be solely attributable to Acthar.

‡Dosage and frequency of Acthar should be individualized according to the medical condition, severity of the disease, and initial response of the patient. Recommended dosing from the Acthar label is 40-80 units (0.5-1 mL) subcutaneously or intramuscularly every 1-3 days.4

Safety findings

3 patients discontinued due to worsening of preexisting conditions or other adverse effects, including hypertension (n=2), hyperglycemia (n=1), and weight gain (n=2)5

No other adverse events were reported during treatment with Acthar5

Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.4

Warnings and Precautions

The adverse effects of Acthar are related primarily to its steroidogenic effects

Acthar may increase susceptibility to new infection or reactivation of latent infections

Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment

Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms

Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored

Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy

Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding

Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated

Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis

Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms

Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver

Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients

Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy

Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain

Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.